Interleukin-2 in Treating Children Who Have Undergone Bone Marrow Transplantation for Acute Myeloid Leukemia
- Conditions
- Leukemia
- Interventions
- Biological: aldesleukin
- Registration Number
- NCT00009698
- Lead Sponsor
- Children's Oncology Group
- Brief Summary
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of interleukin-2 in treating children who have undergone bone marrow transplantation for acute myeloid leukemia.
- Detailed Description
OBJECTIVES: I. Determine the maximum tolerated dose of interleukin-2 after autologous bone marrow transplantation in pediatric patients with acute myeloid leukemia. II. Determine toxic effects of this regimen in these patients.
OUTLINE: This is a dose escalation study. Patients receive interleukin-2 (IL-2) subcutaneously on days 1-7, 9-14, and 16-22. On days 8 and 15, patients receive IL-2 IV over 2 hours. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 6-9 patients receive escalating doses of IL-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 2 of 9 patients experience dose-limiting toxicity. Patients are followed every 6 months for 4 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 6-27 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description All patients aldesleukin Day 1 through day 7, days 9-14 and days 16-22: The assigned dose of IL-2 will be administered SQ. On days 8 and 15, IL-2 will be administered as a 2 hour intravenous infusion of one million units/M2 of IL-2. After day 22 there will be a 7 day rest period before beginning the next cycle. The next cycle will repeat just as above. This will be repeated for a maximum of 4 total cycles of 21 days of IL-2 therapy. The maintenance dose of IL-2 will always be the same as given during cycle one, unless there is dose limiting toxicity.
- Primary Outcome Measures
Name Time Method To determine the maximum tolerated dose (MTD) of IL-2 2 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (119)
All Children's Hospital
🇺🇸St. Petersburg, Florida, United States
St. Mary's Hospital
🇺🇸West Palm Beach, Florida, United States
Hope Children's Hospital
🇺🇸Oak Lawn, Illinois, United States
Maine Children's Cancer Program
🇺🇸Portland, Maine, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Driscoll Children's Hospital
🇺🇸Corpus Christi, Texas, United States
St. Christopher's Hospital for Children
🇺🇸Philadelphia, Pennsylvania, United States
Texas Oncology P.A.
🇺🇸Dallas, Texas, United States
Naval Medical Center, Portsmouth
🇺🇸Portsmouth, Virginia, United States
West Virginia University Hospitals
🇺🇸Morgantown, West Virginia, United States
Boston Floating Hospital Infants and Children
🇺🇸Boston, Massachusetts, United States
Cardinal Glennon Children's Hospital
🇺🇸Saint Louis, Missouri, United States
James H. Quillen College of Medicine
🇺🇸Johnson City, Tennessee, United States
Scott and White Clinic
🇺🇸Temple, Texas, United States
San Jorge Childrens Hospital
🇵🇷Santurce, Puerto Rico
Swiss Pediatric Oncology Group Bern
🇨🇭Bern, Switzerland
Baylor College of Medicine
🇺🇸Houston, Texas, United States
University of Miami-Jackson Memorial Hospital Medical Center
🇺🇸Miami, Florida, United States
Miami Children's Hospital
🇺🇸Miami, Florida, United States
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States
Kaiser Permanente-Southern California Permanente Medical Group
🇺🇸San Diego, California, United States
Children's Hospital and Health Center
🇺🇸San Diego, California, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
MBCCOP - South Texas Pediatric
🇺🇸San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Children's Hospital of Michigan
🇺🇸Detroit, Michigan, United States
St. John's Hospital and Medical Center
🇺🇸Detroit, Michigan, United States
Oklahoma Memorial Hospital
🇺🇸Oklahoma City, Oklahoma, United States
CCOP - Columbia River Program
🇺🇸Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center
🇺🇸Portland, Oregon, United States
CCOP - Florida Pediatric
🇺🇸Tampa, Florida, United States
Midwest Children's Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
Sutter Cancer Center
🇺🇸Sacramento, California, United States
Walt Disney Memorial Cancer Institute
🇺🇸Orlando, Florida, United States
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
Yale Comprehensive Cancer Center
🇺🇸New Haven, Connecticut, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States
University of California San Diego Cancer Center
🇺🇸La Jolla, California, United States
Lucile Packard Children's Hospital at Stanford
🇺🇸Palo Alto, California, United States
Kaiser Permanente Medical Center - Santa Clara
🇺🇸Santa Clara, California, United States
Children's Hospital of Southwest Florida
🇺🇸Fort Myers, Florida, United States
Broward General Medical Center
🇺🇸Fort Lauderdale, Florida, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Nemours Children's Clinic
🇺🇸Jacksonville, Florida, United States
Sylvester Cancer Center, University of Miami
🇺🇸Miami, Florida, United States
Baptist Hospital of Miami
🇺🇸Miami, Florida, United States
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
Children's Memorial Hospital, Chicago
🇺🇸Chicago, Illinois, United States
Rush-Presbyterian-St. Luke's Medical Center
🇺🇸Chicago, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
Saint Jude Midwest Affiliate
🇺🇸Peoria, Illinois, United States
Eastern Maine Medical Center
🇺🇸Bangor, Maine, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Keesler Medical Center - Keesler AFB
🇺🇸Keesler AFB, Mississippi, United States
University of Missouri-Columbia Hospital and Clinics
🇺🇸Columbia, Missouri, United States
CCOP - Northern New Jersey
🇺🇸Hackensack, New Jersey, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Mission Saint Joseph's Health System
🇺🇸Asheville, North Carolina, United States
Schneider Children's Hospital
🇺🇸New Hyde Park, New York, United States
University of New Mexico School of Medicine
🇺🇸Albuquerque, New Mexico, United States
University of Rochester Cancer Center
🇺🇸Rochester, New York, United States
State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
State University of New York Health Sciences Center - Stony Brook
🇺🇸Stony Brook, New York, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Presbyterian Healthcare
🇺🇸Charlotte, North Carolina, United States
East Carolina University School of Medicine
🇺🇸Greenville, North Carolina, United States
Natalie Warren Bryant Cancer Center
🇺🇸Tulsa, Oklahoma, United States
Children's Hospital of Greenville Hospital System
🇺🇸Greenville, South Carolina, United States
Saint Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Cook Children's Medical Center - Fort Worth
🇺🇸Fort Worth, Texas, United States
San Antonio Military Pediatric Cancer and Blood Disorders Center
🇺🇸Lackland Air Force Base, Texas, United States
Cancer Center at the University of Virginia
🇺🇸Charlottesville, Virginia, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Carilion Roanoke Community Hospital
🇺🇸Roanoke, Virginia, United States
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States
West Virginia University Medical School-Charleston
🇺🇸Charleston, West Virginia, United States
Royal Children's Hospital
🇦🇺Parkville, Victoria, Australia
Alberta Children's Hospital
🇨🇦Calgary, Alberta, Canada
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Children's Hospital of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada
Children's Hospital
🇨🇦Hamilton, Ontario, Canada
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Hopital Sainte Justine
🇨🇦Montreal, Quebec, Canada
Centre Hospitalier de L'Universite Laval
🇨🇦Sainte Foy, Quebec, Canada
Academisch Ziekenhuis Groningen
🇳🇱Groningen, Netherlands
Laval University Medical Center
🇨🇦Sainte-Foy, Quebec, Canada
Clinique de Pediatrie
🇨🇭Geneva, Switzerland
Centre Hospitalier Universitaire Vaudois
🇨🇭Lausanne, Switzerland
University of South Alabama Medical Center
🇺🇸Mobile, Alabama, United States
Vermont Cancer Center
🇺🇸Burlington, Vermont, United States
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
St. Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Shands Hospital and Clinics, University of Florida
🇺🇸Gainesville, Florida, United States
MBCCOP - LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
CCOP - Ochsner
🇺🇸New Orleans, Louisiana, United States
Massey Cancer Center
🇺🇸Richmond, Virginia, United States
McGill University Health Center - Montreal Children's Hospital
🇨🇦Montreal, Quebec, Canada
Tripler Army Medical Center
🇺🇸Honolulu, Hawaii, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States